What is the minimum number of migraine days per month required for Nurtec (rimegepant) approval?

Minimum Number of Migraine Days for Nurtec (Rimegepant) Approval

For Nurtec (rimegepant) approval, patients need to have at least 8 migraine days per month to qualify for preventive treatment, as defined by chronic migraine criteria. 1

Understanding Migraine Classifications and Treatment Indications

Migraine Classification:

• Episodic migraine: Headaches occurring on fewer than 15 days per month 2
• Chronic migraine: Headache occurring on ≥15 days/month for >3 months, with migraine features on ≥8 days/month 1

Treatment Indications:

1. Acute treatment: All migraine patients need symptomatic treatment for individual attacks 3
2. Preventive treatment: Indicated when:
   • Patients have more than 2 headaches per week (≥8 days/month) 3
   • Headaches occur on ≥15 days/month for >3 months (chronic migraine) 1
   • Episodic migraine occurs frequently or treatment does not provide adequate response 1

Nurtec (Rimegepant) Approval Criteria

Rimegepant has dual approval for:

1. Acute treatment: For migraine with or without aura in adults (no minimum frequency requirement) 4
2. Preventive treatment: For episodic migraine in adults 4
   • Clinical trials for preventive use enrolled patients with 4-14 moderate to severe migraine attacks per month 5, 6
   • However, guidelines specify that preventive treatment is indicated when patients have ≥8 migraine days per month 1

Treatment Algorithm for Migraine

First-line treatments:

• NSAIDs (ibuprofen, naproxen, aspirin) or acetaminophen for acute treatment 1
• Consider combination therapy (triptan with NSAID or acetaminophen) for improved efficacy 1

Second-line treatments:

• Triptans for moderate to severe attacks 1, 7

Third-line treatments:

• CGRP antagonists (gepants) like rimegepant when patients don't tolerate or have inadequate response to combination therapy 1
• Ergot alkaloids (dihydroergotamine) as an alternative third-line option 1

Fourth-line treatment:

• Ditan (lasmiditan) when patients don't respond to all other treatments 1

Important Considerations and Cautions

• Medication overuse headache risk: Can occur with NSAIDs (≥15 days/month) or triptans (≥10 days/month) 1, 7
• Cost considerations: CGRP antagonists-gepants like rimegepant have significantly higher costs than first-line treatments, with annualized WAC ranging from $4,959 to $5,994 1
• Lifestyle modifications: Staying hydrated, regular meals, sufficient sleep, regular exercise, stress management, and trigger avoidance are important adjuncts to pharmacological treatment 1
• Treatment timing: Begin treatment as soon as possible after migraine onset for improved efficacy 1

Monitoring and Follow-up

• Efficacy of preventive therapy should be assessed after several weeks or months 1
• For CGRP antagonists like rimegepant, efficacy should be assessed after 3-6 months 1
• Consider pausing preventive treatment after 6-12 months of successful therapy to determine if it can be stopped 1

Remember that while rimegepant is approved for both acute and preventive treatment of migraine, its use as a preventive treatment is typically reserved for patients with at least 8 migraine days per month, based on established criteria for chronic migraine.